Favourable opinion for reimbursement only in patients:
with contraindications to MRI, in:
diagnostic dead end situations;
locoregional staging assessment;
tumour assessment before and after neoadjuvant chemotherapy
without contraindications to MRI, in locoregional staging assessment or before/after neoadjuvant chemotherapy, for the assessment of tumour size, in particular for its perfect match with mammography images.
Unfavourable opinion for reimbursement in the other situations covered by the MA indication.
Clinical Benefit
Substantial
The clinical benefit of ULTRAVIST 300 mg and 370 mg iodine/mL (iopromide) solution for injection is substantial only in patients:
with contraindications to MRI, in:
diagnostic dead end situations;
locoregional staging assessment;
tumour assessment before and after neoadjuvant chemotherapy;
without contraindications to MRI, in locoregional staging assessment or before/after neoadjuvant chemotherapy, for the assessment of tumour size, in particular for its perfect match with mammography images.
Insufficient
The clinical benefit of ULTRAVIST 300 mg and 370 mg iodine/mL (iopromide) solution for injection is insufficient to justify public funding cover in the other MA situations.
Clinical Added Value
no clinical added value
Considering:
the data and conclusions of the report assessing the value of dual-energy contrast-enhanced spectral mammography in the diagnostic strategy for breast cancer produced by the HAS in 2021, and, in particular, the clinical situations in which the value of contrast-enhanced mammography has been recognised;
the diagnostic performance of contrast-enhanced mammography with ULTRAVIST based on publications in the literature in the same clinical situations as those explored in the 2021 report;
the already well established safety profile of ULTRAVIST, with no new data calling into question this safety profile;
the medical need currently partially met by the existence of diagnostic alternatives,
the Committee deems that ULTRAVIST 300 mg and 370 mg iodine/mL (iopromide) solution for injection provides no clinical added value (CAV V) in the current care pathway, which includes the clinically relevant comparators cited.
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